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Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes (SAMBA)

This study is currently recruiting participants.
Verified October 2012 by Metabolic Fitness Association, Italy
Sponsor:
Collaborator:
University of Roma La Sapienza
Information provided by (Responsible Party):
Giuseppe Pugliese, Metabolic Fitness Association, Italy
ClinicalTrials.gov Identifier:
NCT01600924
First received: May 16, 2012
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  Purpose

This project will assess the independent predictors of impaired muscle and bone strength through a longitudinal observation of a cohort of subjects with type 1 and 2 diabetes consecutively attending an outpatients diabetes clinics for the annual screening of complications.


Condition
Type 1 Diabetes
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Metabolic Fitness Association, Italy:

Primary Outcome Measures:
  • Independent predictors of reduced muscle and bone strength [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Baseline parameters predicting reduction of muscle and bone strength


Secondary Outcome Measures:
  • Relation of changes in predictors with reduced muscle and bone strength [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Relation of changes over time in predictors with reduced muscle and bone strength


Biospecimen Retention:   Samples Without DNA

Whole blood, plasma, serum and urine samples


Estimated Enrollment: 500
Study Start Date: October 2012
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Outpatients clinics

Criteria

Inclusion Criteria:

  • Patients with type 1 or 2 diabetes

Exclusion Criteria:

  • Patients with any condition precluding mobility
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01600924

Contacts
Contact: Giuseppe Pugliese, MD, PhD +39 06 33775440 giuseppe.pugliese@uniroma1.it

Locations
Italy
University of Rome La Sapienza, Department of Clinical and Molecular Medicine, Sant'Andrea Hospital, Diabetes Unit Recruiting
Rome, RM, Italy, 00189
Contact: Laura Salvi, MD     +39 0633775249     adamas83@hotmail.it    
Sub-Investigator: Laura Salvi, MD            
Sponsors and Collaborators
Metabolic Fitness Association, Italy
University of Roma La Sapienza
Investigators
Study Director: Stefano Balducci, MD Sant'Andrea Hospital, Diabetes Unit
  More Information

Additional Information:
Study protocol  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Giuseppe Pugliese, MD, PhD, Metabolic Fitness Association, Italy
ClinicalTrials.gov Identifier: NCT01600924     History of Changes
Other Study ID Numbers: MFA-12-02
Study First Received: May 16, 2012
Last Updated: October 10, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Metabolic Fitness Association, Italy:
diabetes mellitus
muscle strength
bone strength
cardiovascular risk factors
diabetic complications

Additional relevant MeSH terms:
Congenital Abnormalities
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013